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NCT Number: NCT07359872

Relaxin Therapy for Atrial Fibrillation

Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosed with AF and scheduled for elective catheter ablation for AF

Exclusion criteria

  • Enrollment in another Greater than Minimal Risk Study
  • Pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized
  • Females who plan to become pregnant during the trial period
  • Patients diagnosed with "permanent" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)
  • Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.
  • Patients unable to tolerate Relaxin therapy or unable or unwilling to provide informed consent

Treatment and study plan

relaxin

Drug

subcutaneous injections of Relaxin once daily

Placebo

Drug

subcutaneous injections of Placebo once daily

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 390 days

    The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Ratio of the average daily AF burden before and after treatment

    Time frame: 390 days

    The Primary Efficacy Outcome includes the distribution of the ratio of the average daily AF burden before and after treatment over time. The daily AF burden is defined as the daily AF duration multiplied by the number of AF events including atrial ectopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

(412) 822-2222

Sponsors and collaborators

Lead sponsor

Deeptankar DeMazumder

Fed

Collaborators

  • McGowan Institute for Regenerative Medicine, University of Pittsburgh
  • Relaxera Pharmaceuticals
  • Relaxera Pharmazeutische Gesellschaft mbH & Co. KG

Registry information

Acronym: Relax-in-AF

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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